Generic Drug Submissions and Approval

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Feb 05, 2009 End Date/Time: Feb 06, 2009
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Description

Preparing for Legal and Regulatory Requirements

A Regulatory Affairs Course with Comprehensive & Interactive Discussions on:

- Guidance and Requirements for ANDA/ANDS Approval
- Brand versus Generic Legal Issues
- Trade Dress Requirements
- European Registration System for Generics
- Impact of New EC Laws on Data Exclusivity
- INDIA and CHINA - Emerging Generic Strategies
- How to Submit a Quality Dossier to Reduce Approval Time
- The 505(b)(2) Application and Approval Route
- Forfeiture of 180-day Exclusivity
- Legal Challenges to the 505(b)(2) Process
- Labeling Requirements for ANDA/ANDS Approval
- Post-Approval Reporting Requirements for ANDA Amendments
- Field Alerts and Deviation Reports
- The DMF Filing as Part of the Drug Submission

Interactive Discussion:

- Preparing a Regulatory Submission in CTD Format

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